A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of Alirocumab (SAR236553/REGN727) on the Occurrence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome

Time from randomization to first occurrence of one of the following clinical events: CHD death, any non-fatal MI, fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization [ Time Frame: Up to Month 64 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to the first occurrence of any CHD event, major CHD event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic stroke, all cause mortality [ Time Frame: Up to Month 64 ] [ Designated as safety issue: No ]

Change from baseline in blood lipids and lipoprotein levels [ Time Frame: Up to Month 64 ] [ Designated as safety issue: No ]

The maximum study duration will be 64 months, including up to a 4-month run-in period, 60 months randomized treatment period.

Number of patients aged from 18 to 64 years and >= 65 years old are based on the number of randomized patients (18600 patients).

Eligibility

Ages Eligible for Study:

40 Years and older (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion criteria :

Recently (< 52 weeks) hospitalized for ACS.

Exclusion criteria:

Age < 40 years.

ACS event occurring more than 52 weeks prior to randomization visit.

LDL-C likely to be <70 mg/dL (<1.81 mmo/L) with evidence-based medical and dietary management of dyslipidemia.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01663402